Identifying risk factors for infections in children with drug-resistant bacteria
Official title: A Retrospective Single Center Study of the Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in PICU Hospitalized Children
Run by Children's Hospital of Fudan University · NCT04535661 · Data updated 2026-11-12
This study looks at children in the hospital to see what factors might lead to infections from tough-to-treat bacteria called carbapenem-resistant Enterobacteriaceae.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 29 Days to 18 Years |
| Sex | All |
| Enrollment | 536 (estimated) |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | March 1, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT04535661 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children who were hospitalized in the PICU of Children's Hospital of Fudan University during the specified time frame.
✕Probably not a fit
Patients who were discharged from the PICU within 48 hours or had a positive culture for CRE prior to admission may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on children hospitalized in the pediatric intensive care unit (PICU) at Children's Hospital of Fudan University from January 2018 to December 2019. The aim is to identify risk factors associated with colonization or infection by carbapenem-resistant Enterobacteriaceae (CRE) and to analyze the microbiological characteristics of the CRE isolates. By reviewing clinical and demographic data from electronic health records, the study will categorize patients based on their culture results into non-CRE, CRE colonization, and CRE infection groups. This research addresses a critical gap in understanding the epidemiology of CRE in pediatric patients.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention and treatment strategies for infections caused by carbapenem-resistant bacteria in children.
How similar studies have gone: While there is limited data on similar studies specifically in pediatric populations, the investigation of risk factors for drug-resistant infections has shown promise in other settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All children hospitalized in PICU of Children's Hospital of Fudan University from January 2018 to December 2019. Exclusion Criteria: * discharge within 48 hours * patients had a positive culture for CRE before admission * incomplete clinical and demographic data
Where it's running
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Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Principal investigator: Gangfeng Yan — Children's Hospital of Fundan University
- Study coordinator: Gangfeng Yan
- Email: jinyi036@126.com
- Phone: +8615900603082
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.